BACKGROUND Sentinel-lymph-node biopsy is associated with increased melanoma-specific survival (i.e., survival until death from melanoma) among patients with node-positive intermediate-thickness melanomas (1.2 to 3.5 mm). The value of completion lymph-node dissection for patients with sentinel-node metastases is not clear. METHODS In an international trial, we randomly assigned patients with sentinel-node metastases detected by means of standard pathological assessment or a multimarker molecular assay to immediate completion lymph-node dissection (dissection group) or nodal observation with ultrasonography (observation group). The primary end point was melanoma-specific survival. Secondary end points included disease-free survival and the cumulative rate of nonsentinel-node metastasis. RESULTS Immediate completion lymph-node dissection was not associated with increased melanoma-specific survival among 1934 patients with data that could be evaluated in an intention-to-treat analysis or among 1755 patients in the per-protocol analysis. In the per-protocol analysis, the mean (±SE) 3-year rate of melanoma-specific survival was similar in the dissection group and the observation group (86±1.3% and 86±1.2%, respectively; P=0.42 by the log-rank test) at a median follow-up of 43 months. The rate of disease-free survival was slightly higher in the dissection group than in the observation group (68±1.7% and 63±1.7%, respectively; P=0.05 by the log-rank test) at 3 years, based on an increased rate of disease control in the regional nodes at 3 years (92±1.0% vs. 77±1.5%; P<0.001 by the log-rank test); these results must be interpreted with caution. Nonsentinel-node metastases, identified in 11.5% of the patients in the dissection group, were a strong, independent prognostic factor for recurrence (hazard ratio, 1.78; P=0.005). Lymphedema was observed in 24.1% of the patients in the dissection group and in 6.3% of those in the observation group. CONCLUSIONS Immediate completion lymph-node dissection increased the rate of regional disease control and provided prognostic information but did not increase melanoma-specific survival among patients with melanoma and sentinel-node metastases. (Funded by the National Cancer Institute and others; MSLT-II ClinicalTrials.gov number, NCT00297895.)

In our series, breast desmoids presented as palpable masses suspicious for carcinoma clinically and radiographically. Therapy remains primarily surgical, and core biopsy aided in operative planning. Recurrences are common, with younger age and possibly positive margin status and larger tumor size associated with increased risk of recurrence. As 5/9 patients with positive and 3/19 patients with negative margins experienced recurrences, clinical judgment should be used prior to extensive and potentially deforming resections.

Importance No consensus exists regarding the definition of “high risk” surgery in older adults. An inclusive and precise definition of high risk surgery may be useful for surgeons, patients, researchers and hospitals. Objectives To develop a list of “high risk” operations. Design 1) Retrospective cohort study; and 2) Modified Delphi procedure. Setting All Pennsylvania acute care hospitals (Pennsylvania Health Care Cost Containment Council [PHC4], 2001–2007) and a nationally-representative sample of U.S. acute care hospitals (Nationwide Inpatient Sample [NIS], HCUP, AHRQ 2001–2006). Patients Admissions 65 and older to PHC4 hospitals and admissions 18 and older to NIS hospitals. Methods We identified ICD-9 CM procedure codes associated with >1% inpatient mortality in PHC4. We used a modified Delphi technique with 5 board certified surgeons to further refine this list by excluding non-operative procedures and operations that were unlikely to be the proximate cause of mortality and were instead a marker of critical illness (e.g., tracheostomy). We then cross-validated this list of ICD-9CM codes in the NIS. Main Outcomes Measures 1) Delphi consensus of at least 4/5 panelists; 2) proportion agreement in the NIS. Results Among 4,739,522 admissions 65 and older in PHC4, 2,569,589 involved a procedure, encompassing 2,853 unique procedures. Of 1,130 procedures associated with a crude inpatient mortality of at least 1%, 264 achieved consensus as high risk operations by Delphi. The observed inpatient mortality in the NIS was ≥ 1% for 227/264 (86%) of the procedures in patients age 65 and older. The pooled inpatient mortality rate for these identified high risk procedures performed on patients age ≥65 was double the inpatient mortality for correspondingly identified high risk operations for patients less than 65 (6% vs. 3%). Conclusions We developed a list of procedure codes that can be used to identify “high risk” surgical procedures in claims data. This list of “high risk” operations can be used to standardize the definition of high risk surgery in quality and outcomes-based studies and design targeted clinical interventions.

BACKGROUND Multiple studies have suggested that resection of the primary tumor improves survival in patients with stage IV breast cancer, yet in the era of targeted therapy, the relation between surgery and tumor molecular subtype is unknown. The objective of the current study was to identify subsets of patients who may benefit from primary tumor treatment and assess the frequency of local disease progression. METHODS Patients presenting with stage IV breast cancer and intact primary tumors (n = 186) were identified from a prospectively maintained clinical database (2000-2004) and clinical data were abstracted (grading determined according to the American Joint Committee on Cancer staging system). RESULTS Surgery was performed in 69 (37%) patients: 34 (49%) patients with unknown metastatic disease at the time of surgery, 15 (22%) patients for local control, 14 (20%) patients for palliation, and in 6 (9%) patients to obtain tissue. Surgical patients were more likely to be HER-2/neu negative for HER-2/neu (P = .001), and to have smaller tumors (P = .05) and solitary metastasis (P <.001). Local therapy included axillary lymph node clearance in 33 (48%) patients and postoperative radiotherapy in 9 (13%) patients. The median survival was 35 months. Cox regression analysis identified estrogen receptor (ER) positivity (hazard ratio [HR], 0.47; 95% confidence interval [95% CI], 0.29-0.76), progesterone receptor positivity (HR, 0.57; 95% CI, 0.36-0.90), and HER-2/neu amplification (HR, 0.51; 95% CI, 0.34-0.77) as being predictive of improved survival. There was a trend toward improved survival with surgery (HR, 0.71; 95% CI, 0.47-1.06). On exploratory analyses, surgery was found to be associated with improved survival in patients with ER/PR positive or HER-2/neu-amplified disease (P = .004). No survival benefit was observed in patients with triple-negative disease. CONCLUSIONS Although a trend toward improved survival with surgery was observed, it was noted most strongly in patients with ER/PR positive and/or HER-2/neu-amplified disease. This suggests that the impact of local control is greatest in the presence of effective targeted therapy, and supports the need for further study to define patient subsets that will benefit most.

Background Individuals ≥80 years of age represent an increasing proportion of colon cancer diagnoses. Selecting these patients for elective surgery is challenging due to diminished overall health, functional decline, and limited data to guide decisions. The objective was to identify overall health measures that are predictive of poor survival after elective surgery in these oldest-old colon cancer patients. Methods Medicare beneficiaries ≥80 years who underwent elective colectomy for stage I-III colon cancer from 1992-2005 were identified from the Surveillance, Epidemiology and End Results(SEER)-Medicare database. Kaplan-Meier survival analysis determined 90-day and 1-year overall survival. Multivariable logistic regression assessed factors associated with short-term post-operative survival. Results Overall survival for the 12,979 oldest-old patients undergoing elective colectomy for colon cancer was 93.4% and 85.7%, at 90-days and 1-year. Older age, male gender, frailty, increased hospitalizations in prior year, and dementia were most strongly associated with decreased survival. In addition, AJCC stage III (versus stage I) disease and widowed (versus married) were highly associated with decreased survival at 1-year. Although only 4.4% of patients were considered frail, this had the strongest association with mortality, with an odds ratio of 8.4 (95% confidence interval 6.4-11.1). Discussion Although most oldest-old colon cancer patients do well after elective colectomy, a significant proportion (6.6%) dies by post-operative day 90 and frailty is the strongest predictor. The ability to identify frailty through billing claims is intriguing and suggests the potential to prospectively identify, through the electronic medical record, patients at highest risk of decreased survival.

Importance Evolving data on the effectiveness of post-mastectomy radiation therapy (PMRT) have led to changes in NCCN recommendations, counseling providers to “strongly consider” PMRT for breast cancer patients with tumors ≤5cm and 1-3 positive nodes; however, anticipated PMRT may lead to delay or omission of reconstruction which can have cosmetic, quality of life, and complication implications for patients. Objective To determine whether revised guidelines have increased PMRT and impacted receipt of breast reconstruction. We hypothesized that: 1) PMRT would increase for women affected by the revised guidelines while remaining stable in other cohorts, and 2) that these women would have decreased receipt of breast reconstruction while reconstruction increased in other groups. Design A retrospective, population-based cohort study Setting Surveillance, Epidemiology, and End Results (SEER) data from 2000 – 2011. Participants Women with stage I-III breast cancer undergoing mastectomy were identified. Our analytic sample (n=62,442) was divided into cohorts based on current NCCN radiation recommendations: “Radiation Recommended” (tumors >5 cm or ≥4 positive lymph nodes), “Strongly Consider Radiation” (tumor ≤5cm, 1-3 positive nodes), and “Radiation Not Recommended” (tumors ≤5cm, no positive nodes). Main Outcome Measure(s) We used joinpoint regression analysis to evaluate temporal trends in our outcomes of interest: receipt of PMRT and receipt of breast reconstruction. Results Rates of PMRT were unchanged in the “Radiation Recommended” and “Radiation Not Recommended” cohorts over the study period. In contrast, receipt of PMRT for the “Strongly Consider Radiation” cohort was unchanged until 2007, then significantly increased (APC 9.0%, p=0.013). Breast reconstruction increased across all cohorts. Despite increasing receipt of PMRT, the “Strongly Consider Radiation” cohort maintained a consistent increase in reconstruction (APC 7.5%) throughout the study period. This is similar to the increase in reconstruction observed for the “Radiation Recommended” (10.7%) and “Radiation Not Recommended (8.4%) cohorts. Conclusions and Relevance NCCN guideline changes have increased PMRT receipt for patients with tumors ≤5cm and 1-3 positive nodes without an associated decrease in receipt of reconstruction. This may represent increasing provider comfort with the prospect of irradiating a new breast reconstruction, and may have significant cosmetic and quality of life implications for patients.

The 2013 Institute of Medicine report investigating cancer care concluded that the cancer care delivery system is in crisis due to an increased demand for care, increasing complexity of treatment, decreasing work force, and rising costs. Engaging patients and incorporating evidence-based care into routine clinical practice are essential components of a high-quality cancer delivery system. However, a gap currently exists between the identification of beneficial research findings and the application in clinical practice. Implementation research strives to address this gap. In this review, we discuss key components of high-quality implementation research. We then apply these concepts to a current cancer care delivery challenge in women’s health, specifically the implementation of a surgery decision aid for women newly diagnosed with breast cancer.

Background Use of neoadjuvant chemotherapy for breast cancer is increasing. The objective was to examine risk of post-operative wound complications in patients receiving neoadjuvant chemotherapy for breast cancer. Methods Patients undergoing breast surgery from 2005–2010 were selected from the American College of Surgeons National Surgical Quality Improvement Program database. Patients were included if pre-operative diagnosis suggested malignancy and an axillary procedure was performed. A stepwise multivariable regression analysis of predictors of post-operative wound complications, overall and stratified by breast surgery type, was performed. Our primary variable of interest was receipt of neoadjuvant chemotherapy. Results Of 44,533 patients, 4.5% received neoadjuvant chemotherapy. Wound complications were infrequent with or without neoadjuvant chemotherapy (3.4% vs. 3.1%, p= 0.4). Smoking, functional dependence, obesity, diabetes, hypertension and mastectomy were associated with wound complications. No association with neoadjuvant chemotherapy was seen (OR 1.01 [CI 0.78–1.32]). However, a trend towards increased complications in neoadjuvant patients undergoing mastectomy with immediate reconstruction (OR 1.58 [CI 0.98–2.58]) was observed. Conclusion Breast post-operative wound complications are infrequent and not associated with neoadjuvant chemotherapy. However, given the trend towards increased complications in patients undergoing mastectomy with immediate reconstruction, neoadjuvant chemotherapy should be one of many factors considered when making multidisciplinary treatment decisions.